Surgeons have developed a number of methods and techniques to treat a variety of medical anomalies in the abdomen and gastrointestinal tract. These procedures often involve stapling and must be performed during open surgery or rigid laparoscopic surgery because there is no device or reliable method for placing staples using flexible endoscopes. Suturing has the same current limitations and as such the medical community is unable to perform surgical procedures via natural body openings using flexible endoscopes. Surgical procedures for removing diseased organs, gastric bypass surgery performed in morbidly obese patients, and a variety of other surgical procedures must be performed during open or laparoscopic surgery.
Providing the physicians with a flexible stapling device to be used in conjunction with a flexible endoscope would significantly reduce the length and complexity of the surgery. Consequently, morbidity and mortality would be reduced; hospital stay shortened, and cost savings provided. Because flexible endoscopic procedures are typically performed under conscious sedation and are much less invasive, they are naturally less traumatic to the body. Convalescence is significantly shortened, postoperative pain is virtually eliminated and patients are ambulatory within hours after an endoscopic procedure.
The only means of treating a problem that requires surgery in the abdomen is through open or laparoscopic surgery. Bypass and gastric restrictive surgery for the morbidly obese patient is being performed during open or laparoscopic surgery. These operations take five to seven hours and are performed under general anesthesia. The recovery typically takes six weeks to three months if the operation is successful. Recently, a new procedure has been introduced during which a band is placed around the stomach. This operation is less complex than the abovementioned procedures but is also being performed through open or laparoscopic means.
These complex and invasive surgical procedures require general anesthesia, surgical incisions, multiple days in the hospital, and significant use of medication for postoperative pain and lengthy periods of convalescence. Surgical procedures to treat morbidly obese patients have a high incidence of complications and thus limit the number of patients that can benefit from these procedures. These operations are currently performed through a large abdominal incision. The physician excludes or closes off a large portion of the stomach. In addition, a portion of the small intestine is bypassed, and a new connection to the stomach is made. Oftentimes the patient has had prior surgery causing adhesions, which bind the intestines together. The surgeon has to dissect these adhesions and free the bowel in order to get to the operative site. This procedure is quite difficult, and has to be performed before the actual bypass and gastric stapling operation has even begun. This surgery can also be performed laparoscopically. However, while the incisions are smaller, the abdomen is filled with a large amount of gas in order to distend it and enable the surgeon to perform the operation. The surgery is more difficult and typically takes two to three hours longer than the open operation. This requires longer anesthesia time increasing the danger to the patient. The distended abdomen impinges on the patient's lungs decreasing breathing capacity and adding morbidity. While this is a less invasive procedure than open surgery, it still entails significant complications and lengthy patient convalescence. Furthermore, because the surgery takes longer than open surgery, risk to the patient is increased from prolonged general anesthesia. The less traumatic banding procedure is less complicated; however, reports of band slippage and postoperative infection exist. In addition, results have been poor.